A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced HCC with DEB-TACE Combined with SALOX-HAIC
NCT ID: NCT06823050
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
59 participants
OBSERVATIONAL
2025-03-01
2028-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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DEB-TACE+ SALOX-HAIC+Apatinib+Carilizumab
Drug-eluting bead transarterial chemoembolization combined with SALOX-HAIC sequential Apatinib and Carilizumab
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2\. CNLC Ib-IIIa；BCLC：A-C 3. Patient age between 18 and 80，male or female. 4. ECOG 0-1. 5.Expected life span ≥ 3 months. 6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
7\. Child-Pugh A-B. 8.The laboratory tests meet the following requirements: platelets ≥ 50×109/L; hemoglobin ≥ 9g/dL; white blood cells ≥ 4×109/L; neutrophils ≥ 1.5×109/L; serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine test shows that urine protein \< 2+; for patients whose urine routine test at baseline showed urine protein ≥ 2+, 24-hour urine collection should be conducted and the 24-hour urine protein quantification should be \< 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
9\. HBV DNA\<2000 IU/ml. 10. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
11\. Patients sign informed consent, good compliance, cooperate with treatment.
Exclusion Criteria
2\. Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.
3\. Diffuse liver cancer patients. 4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
5\. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
6\. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
7\. Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.
8\. Systemic failure, estimated survival time \<3 months. 9. Severe renal dysfunction. 10. The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.
18 Years
80 Years
ALL
No
Sponsors
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Xuhua Duan
OTHER
Responsible Party
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Xuhua Duan
Associate Professor
Locations
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Deng zhou People's Hospital
Dengzhou, Henan, China
The Second People's Hospital of Jiaozuo
Jiaozuo, Henan, China
Huai He Hospital of Henan University
Kaifeng, Henan, China
Luo Yang Central Hospital
Luoyang, Henan, China
First People's Hospital of Shangqiu
Shangqiu, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhou Kou Central Hospital
Zhoukou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Yanliang Li
Role: primary
Chuntang Qin
Role: primary
Xiang He
Role: primary
Fazhong Li
Role: primary
Zhenhua Tian
Role: primary
Cheng Xing
Role: primary
Other Identifiers
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2025-KY-0112-001
Identifier Type: -
Identifier Source: org_study_id
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